FDA 510(k)

HISPEED ADVANTAGE II

K-Number: K940606 · 1994-08-23

Decision Date1994-08-23

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HISPEED ADVANTAGE II is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1994-08-23 under 510(k) number K940606. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HISPEED ADVANTAGE II?

HISPEED ADVANTAGE II is a medical device that received FDA 510(k) clearance on 1994-08-23. The listed applicant is GE Medical Systems. The 510(k) number is K940606.

When did HISPEED ADVANTAGE II receive FDA 510(k) clearance?

HISPEED ADVANTAGE II received FDA 510(k) clearance on 1994-08-23, under 510(k) number K940606.

Who is the listed applicant for HISPEED ADVANTAGE II?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HISPEED ADVANTAGE II?

The FDA product code for HISPEED ADVANTAGE II is JAK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.